Search results for "Mabs"
Article
New Therapies Present Scaling Challenges
In addition, mammalian cell culture technology has advanced such that producing multi-kilogram quantities of therapeutic mAbs in one batch is now commonplace (1). With a cell therapy, however, establi…
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Impact of Media Components on CQAs of Monoclonal Antibodies
Of these, mAbs comprise large, multi-domain proteins that require complex machinery for proper protein folding, assembly, and post-translation modifications. These modifications can profoundly affect …
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Antibody Production in Microbial Hosts
Rathore, Jyoti Batra
The biopharmaceutical industry is growing exponentially, driven by an ever-increasing demand for monoclonal antibodies (mAbs) and related products that are capable of treating…
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Comparing Protein A Resins for Monoclonal Antibody Purification
As a consequence, downstream processing must accept and handle higher titers of mAbs in harvested cell-culture fluid (HCCF), and vendors of mAb purification technologies must develop chromatography re…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
Different from mAbs
Considering the differences between monoclonal antibody (mAb) production and cell/gene therapy production is also important when establishing a cell/gene therapy facility. Al…
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N-Glycan Analysis of Biotherapeutic Proteins
More than half of all biotherapeutics are glycosylated (2), including monoclonal antibodies (mAbs), Fc-fusion proteins, clotting factors, and cytokines such as erythropoietin. Of these, mAbs represent…
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Preclinical Evaluation of Product Related Impurities and Variants
The reversible nature of the modifications that result in the charge heterogeneity of mAbs (particularly that of acidic variants) makes them susceptible to changes over the course of storage. This nec…
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Process Chromatography: Continuous Optimization
Monoclonal antibodies (mAbs), which today account for approximately 50% of the total revenues of all biopharmaceuticals according to David Westman, global product marketing manager for Cytiva, are typ…
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QbD and PAT in Upstream and Downstream Processing
It is important to note that mAbs are currently the leading area of biopharmaceutical research. One of the key parameters to monitor in the implementation of QbD in mAb production is the glycosylation…
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Advances in Engineering of Protein-Based APIs
Today, monoclonal antibodies (mAbs) have become one of the predominant forms of protein-based biopharmaceuticals, with humanization and fully human monoclonals contributing to their increasing success…